Posttraumatic Stress DisorderNCT06185244
Efficacy of Internet-delivered Trauma-focused CBT for Young People With PTSD
A study testing Therapist-supported internet-delivered trauma-focused CBT and 12 weeks of therapist-supported internet-delivered psychoeducation and stress management/relaxation for both the youth and the care giver. in people with Posttraumatic Stress Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The goal of this clinical trial is to compare therapist-guided internet delivered trauma-focused cognitive behavior therapy (CBT) to an active control condition comprising therapist-guided internet delivered cognitive behavioral therapy containing relaxation techniques and psychoeducation for young people with… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Therapist-supported internet-delivered trauma-focused CBT and 12 weeks of therapist-supported internet-delivered psychoeducation and stress management/relaxation for both the youth and the care giver.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSweden
- Study dates
- 11 Mar 2024to 4 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 13-17 years,
- Primary PTSD diagnosis
- Fluent in Swedish
- Access to the Internet at home or can use vouchers for internet-access to their phone.
- Parent/guardian willing and able to take part in treatment.
Who cannot join
- PTSD is not the primary concern
- Initiation or adjustment of any psychotropic medication within the last 4 weeks prior to commencement of treatment
- Serious mental health symptoms, such as mania, psychosis, alcohol, or substance use disorders or current suicide risk warranting immediate clinical attention.
- Ongoing trauma-focused CBT or Eye movement desensitization and reprocessing Therapy
- Ongoing trauma-related threat
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Erica Mattelin contact
Sweden1 site, 1 recruiting
- Recruiting
Barn och ungdomspsykiatrin, BUP Internetenhet and Save the Children
Stockholm
Maria Bragesjö, PhD
About this study
Official title: Efficacy and Cost Effectiveness of Internet-delivered Trauma-focused CBT for Young People With PTSD
The goal of this clinical trial is to compare therapist-guided internet delivered trauma-focused cognitive behavior therapy (CBT) to an active control condition comprising therapist-guided internet delivered cognitive behavioral therapy containing relaxation techniques and psychoeducation for young people with post-traumatic stress disorder regarding efficacy and cost effectiveness.
Young people with post-traumatic stress disorder will be randomly assigned to receive either 12 weeks of therapist-guided internet delivered trauma-focused cognitive behavior therapy (iTF-CBT) or therapist-guided internet delivered cognitive-behavioral therapy containing relaxation and psychoeducation.
Read the detailed description
There is an urgent need for evidence-based treatments for children with PTSD that can easily be made available to a large number of afflicted. The overall aim of the project is to increase the availability of evidence-based psychological treatments for adolescents with PTSD by developing and evaluating iTF-CBT for this target group. The main objectives are to establish the efficacy, cost-effectiveness, and long-term effects of iTF-CBT for adolescents with PTSD in an RCT (N=140) by comparing guided iTF-CBT with an attention control group consisting of therapist-supported internet-delivered psychoeducation and support.
The study is a single-blind, parallel-group superiority randomized controlled trial with 240 patients (120 per arm) that will compare therapist-guided internet delivered trauma-focused cognitive behavior CBT with therapist-guided internet delivered cognitive-behavioral therapy comprising relaxation and psychoeducation. The primary outcome is the blind-rater administered Clinician-Administered PTSD Scale for DSM-5 (CAPS-5-CA). An internal pilot is built in in the design and the first 20 enrolled participants will not be randomized but receive the active intervention. They will also be asked to participate in qualitative interviews about their experience of the intervention.
Secondary outcomes are cost effectiveness, predictors of clinically meaningful change in symptoms, mediators of change, dropout rate, and negative effects.
Research questions:
- Is guided iTF-CBT more efficacious than an active control condition (therapist-supported internet-delivered psychoeducation and support) in regard to reduction of blinded assessor rated PTSD symptom severity 1-month post-treatment?
- Is guided iTF-CBT more cost-effective than an active control condition (therapist-supported internet-delivered psychoeducation and support) in regard to reduction of blinded assessor rated PTSD symptom severity 1-month post-treatment?
- Are the therapeutic gains of iTF-CBT maintained at long term follow up (6 and 12 months after treatment)?
- How do children, parents and therapists perceive iTF-CBT?
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Therapist-supported internet-delivered trauma-focused CBT, 12 weeks of therapist-supported internet-delivered psychoeducation and stress management/relaxation for both the youth and the care giver.
- Keywords
- PTSD, digital treatment, trauma-focused CBT, therapist-guided
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapist-supported internet-delivered trauma-focused CBTBehavioural
12 weeks of therapist-supported internet-delivered trauma-focused CBT for both the youth and the care giver.
12 weeks of therapist-supported internet-delivered psychoeducation and stress management/relaxation for both the youth and the care giver.Behavioural
12 weeks of therapist-supported internet-delivered psychoeducation and stress management/relaxation for both the youth and the care giver.
| Study group | Role | What they receive |
|---|---|---|
| Therapist-supported internet delivered trauma-focused CBT | Experimental | Therapist-supported internet delivered trauma-focused CBT. The protocol mirrors the exact content of first-line treatment for children with PTSD but is delivered through a digital platform and will comprise of text-based material as well as audio files and video illustrations in an age-appropriate manner that the participant gains access to sequentially. iTF-CBT will be therapist-assisted, and each participant will have a designated therapist to guide them through treatment. Treatment will span over 12 weeks and integrates cognitive, behavioral, interpersonal, and family therapy principles as well as trauma interventions. Parallel to the child's treatment, the caregivers are provided the same components and parenting practices, and joint child-parent activities are included. Participants will have access to a therapist that will guide them through treatment in a text based format. Receives: Behavioral: Therapist-supported internet-delivered trauma-focused CBT |
| Therapist-supported psychoeducation and stress management | Active comparator | Therapist-supported CBT internet-delivered treatment comprising psychoeducation about PTSD, relaxation/stress management techniques and relapse prevention. The treatment will be delivered in a digital platform for twelve weeks. Participants will have access to a therapist that will guide them through treatment in a text-based material as well as audio files and video illustrations in an age-appropriate manner that the participant gains access to sequentially. Receives: Behavioral: 12 weeks of therapist-supported internet-delivered psychoeducation and stress management/relaxation for both the youth and the care giver. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale Children and Adolescent version 5 (CAPS-5-CA)
The CAPS-5-CA is a structured interview that assesses the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria for PTSD (Weathers et al., 2013). Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms. Total Score (Range 0-80 with higher scores representing more PTSD symptoms.
Measured: Baseline, 1-month (primary endpoint), 6-month and 12-month after treatment completion
Secondary outcomes (14)
Change in self-rated symptoms of PTSD and complex PTSD measured by The Child and Adolescent Trauma Screen (CATS-2)
The CATS-2 measures potentially traumatic events (PTEs), posttraumatic stress symptoms (PTSS) and impairment according to DSM-5 and ICD-11 criteria in children and adolescent from 7 to 17 years. In addition to a self-report measure for children and adolescents, the CATS-2 includes a parallel caregiver version. Posttraumatic stress symptoms in the last four weeks are then assessed using 25 items rated on a 4-point. The 25 items map directly onto the diagnostic criteria for PTSD in DSM-5 and ICD-11 PTSD and CPTSD. The DSM-5 PTSD severity score is the sum of items 1-20 (range 0-60), including only the highest score of items 9, 10, 15. The ICD-11 PTSD severity score (range 0-18) is the sum of items 2, 3, 6, 7, 17, 18. The ICD-11 CPTSD score (range 0-36) is the sum of ICD-11 PTSD severity score (2, 3, 6, 7, 17, 18) plus the sum of the ICD-11 DSO severity score (9b, 9d, 10a, 13, 14, 15a). Higher scores represents more PTSD symptoms.
Measured: Baseline, through the treatment period up to 12 weeks and 1-month, 6-month and 12-month after treatment completion
Change in self-rated symptoms of depression as measured by Mood and Feelings Questionnaire (MFQ)
The MFQ consists of a series of 33 descriptive phrases regarding how the subject has been feeling or acting recently. Respondents are asked whether descriptions in the questionnaire are 'true', 'sometimes true' or 'not true' for them over the past two weeks. The MFQ is scored by summing together the point values of responses for each item. The response choices and their designated point values are as follows: "not true" = 0 points, "sometimes true" = 1 point, "true" = 2 points. Higher scores on the MFQ suggest more severe depressive symptoms.
Measured: Baseline, immediately after treatment completion, and 1-month, 6-month and 12-month after treatment completion
Change in psychosocial impairment measured by The Education, Work and Social Adjustment Scale, Youth and Parent (EWSAS)
EWSAS is a short, self-reported instrument consisting of five items about psychosocial impairments rated on a nine-point Likert scale. A higher score means more severe impairment.
Measured: Baseline, immediately after treatment completion, and 1-month, 6-month and 12-month after treatment completion
Change in Treatment Inventory of Costs in Psychiatric Patients (TIC-P)
Self-rated questionnaire on healthcare utilization and productivity losses in patients with a psychiatric disorder. The TIC-P questionnaire measures costs in two dimensions: use of health resources and loss of productivity. Lower cost is better.
Measured: Baseline, immediately after treatment completion, and 1-month, 6-month and 12-month after treatment completion
Adverse events related to treatment measured by the Negative effects questionnaire
Self-rated questionnaire on negative effects. It contains 32 items that are scored on a five point Likert-scale (0-4) and differentiates between negative effects that are attributed to treatment and those possibly caused by other circumstances. The total score of the NEQ ranges from 0 to 80 points, a higher score reflects more negative effects.
Measured: Immediately after treatment completion, 1-month, 6-month and 12-month after treatment completion
Quality of life measured by Assessment of Quality of Life KIDSCREEN-10
Change in subjective psychological, mental and social well-being from baseline to immediately after treatment and follow up . a higher score reflects higher health-related quality of life.
Measured: Immediately after treatment completion, 1-month, 6-month and 12-month after treatment completion
Participants satisfaction with treatment, assessed by The Client Satisfaction Questionnaire (CSQ-8).
The CSQ-8 yields a single score measuring a single dimension of overall satisfaction. An "overall score" is calculated by summing the score on each of the eight scale item. Scores range from 8 to 32, with higher values indicating higher satisfaction.
Measured: Immediately after treatment completion.
Number of completed treatment modules
Data will be gathered on total number of completed modules during the 12 week treatment.
Measured: Baseline up to 12 weeks
Number of messages sent and received in the digital platform
Data will be gathered on total number of messages sent and received back and forth between the participant and the therapist during the 12 week treatment.
Measured: Baseline up to 12 weeks
Number of home work assignments made by the participant during the treatment period
umber of home work assignments made by the participant during the treatment period
Measured: up to 12 weeks
The proportion of participants that conducts the weekly measures and further assessment points
The proportion of participants that conducts the weekly measures and further assessment points
Measured: up to the 6 months follow up
The proportion of participants that go through the entire treatment period
The proportion of participants that go through the entire treatment period
Measured: up to 12 weeks
Number of drop-outs from treatment
Number of drop-outs from treatment
Measured: up to 12 weeks
Participants experience/satisfaction with treatment and assessment procedures through qualitative interviews
Participants experience/satisfaction with treatment and assessment procedures through qualitative interviews
Measured: up to the 6-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start11 Mar 2024
- Primary completion4 Jan 2027 (estimated)
- Study completion4 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Child and Adolescent Psychiatry, Stockholm, Save the Children
- Responsible party
- Principal investigator, Maria Bragesjo, Karolinska Institutet
- Investigators
- Maria Bragesjö, PhD, Principal investigator, Karolinska Institutet/Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185244
- Sponsor's protocol ID
- 2023-06501-01
- Other IDs
- 2023
- Status last verified
- Mar 2024
- First submitted
- 14 Dec 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mattelin E, Weyler H, Andersson R, Paulsen J, Tielman S, Vikgren A, Bondjers K, Serlachius E, Mataix-Cols D, Bragesjo M. Feasibility and acceptability of therapist-guided, asynchronous, internet-delivered trauma-focused CBT for adolescents with PTSD: a single-group feasibility trial in Sweden. BMJ Open. 2026 May 27;16(5):e117024. doi: 10.1136/bmjopen-2026-117024.
PubMed 42203279
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Cost Effectiveness of Internet-delivered Trauma-focused CBT for Young People With PTSD
- ClinicalTrials.gov ID
- NCT06185244
- Acronym / sponsor ID
- 2023-06501-01
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, digital treatment, trauma-focused CBT, therapist-guided
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Child and Adolescent Psychiatry, Stockholm, Save the Children
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 4 Jan 2027 (estimated)
- Study completion
- 4 Jan 2028 (estimated)
- First posted
- 29 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare therapist-guided internet delivered trauma-focused cognitive behavior therapy (CBT) to an active control condition comprising therapist-guided internet delivered cognitive behavioral therapy containing relaxation techniques and psychoeducation for young people with post-traumatic stress disorder regarding efficacy and cost effectiveness.
Young people with post-traumatic stress disorder will be randomly assigned to receive either 12 weeks of therapist-guided internet delivered trauma-focused cognitive behavior therapy (iTF-CBT) or therapist-guided internet delivered cognitive-behavioral therapy containing relaxation and psychoeducation.
Detailed description
There is an urgent need for evidence-based treatments for children with PTSD that can easily be made available to a large number of afflicted. The overall aim of the project is to increase the availability of evidence-based psychological treatments for adolescents with PTSD by developing and evaluating iTF-CBT for this target group. The main objectives are to establish the efficacy, cost-effectiveness, and long-term effects of iTF-CBT for adolescents with PTSD in an RCT (N=140) by comparing guided iTF-CBT with an attention control group consisting of therapist-supported internet-delivered psychoeducation and support.
The study is a single-blind, parallel-group superiority randomized controlled trial with 240 patients (120 per arm) that will compare therapist-guided internet delivered trauma-focused cognitive behavior CBT with therapist-guided internet delivered cognitive-behavioral therapy comprising relaxation and psychoeducation. The primary outcome is the blind-rater administered Clinician-Administered PTSD Scale for DSM-5 (CAPS-5-CA). An internal pilot is built in in the design and the first 20 enrolled participants will not be randomized but receive the active intervention. They will also be asked to participate in qualitative interviews about their experience of the intervention.
Secondary outcomes are cost effectiveness, predictors of clinically meaningful change in symptoms, mediators of change, dropout rate, and negative effects.
Research questions:
- Is guided iTF-CBT more efficacious than an active control condition (therapist-supported internet-delivered psychoeducation and support) in regard to reduction of blinded assessor rated PTSD symptom severity 1-month post-treatment?
- Is guided iTF-CBT more cost-effective than an active control condition (therapist-supported internet-delivered psychoeducation and support) in regard to reduction of blinded assessor rated PTSD symptom severity 1-month post-treatment?
- Are the therapeutic gains of iTF-CBT maintained at long term follow up (6 and 12 months after treatment)?
- How do children, parents and therapists perceive iTF-CBT?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Therapist-supported internet delivered trauma-focused CBT | Experimental | Behavioral: Therapist-supported internet-delivered trauma-focused CBTTherapist-supported internet delivered trauma-focused CBT. The protocol mirrors the exact content of first-line treatment for children with PTSD but is delivered through a digital platform and will comprise of text-based material as well as audio files and video illustrations in an age-appropriate manner that the participant gains access to sequentially. iTF-CBT will be therapist-assisted, and each participant will have a designated therapist to guide them through treatment. Treatment will span over 12 weeks and integrates cognitive, behavioral, interpersonal, and family therapy principles as well as trauma interventions. Parallel to the child's treatment, the caregivers are provided the same components and parenting practices, and joint child-parent activities are included. Participants will have access to a therapist that will guide them through treatment in a text based format. |
| Therapist-supported psychoeducation and stress management | Active comparator | Behavioral: 12 weeks of therapist-supported internet-delivered psychoeducation and stress management/relaxation for both the youth and the care giver.Therapist-supported CBT internet-delivered treatment comprising psychoeducation about PTSD, relaxation/stress management techniques and relapse prevention. The treatment will be delivered in a digital platform for twelve weeks. Participants will have access to a therapist that will guide them through treatment in a text-based material as well as audio files and video illustrations in an age-appropriate manner that the participant gains access to sequentially. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 13-17 years,
- Primary PTSD diagnosis
- Fluent in Swedish
- Access to the Internet at home or can use vouchers for internet-access to their phone.
- Parent/guardian willing and able to take part in treatment.
Key exclusion criteria (5 listed)
- PTSD is not the primary concern
- Initiation or adjustment of any psychotropic medication within the last 4 weeks prior to commencement of treatment
- Serious mental health symptoms, such as mania, psychosis, alcohol, or substance use disorders or current suicide risk warranting immediate clinical attention.
- Ongoing trauma-focused CBT or Eye movement desensitization and reprocessing Therapy
- Ongoing trauma-related threat
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapist-supported internet-delivered trauma-focused CBT12 weeks of therapist-supported internet-delivered trauma-focused CBT for both the youth and the care giver. | Behavioural | Therapist-supported internet delivered trauma-focused CBT |
| 12 weeks of therapist-supported internet-delivered psychoeducation and stress management/relaxation for both the youth and the care giver.12 weeks of therapist-supported internet-delivered psychoeducation and stress management/relaxation for both the youth and the care giver. | Behavioural | Therapist-supported psychoeducation and stress management |
Primary outcome
Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale Children and Adolescent version 5 (CAPS-5-CA)
Time frame: Baseline, 1-month (primary endpoint), 6-month and 12-month after treatment completion
The CAPS-5-CA is a structured interview that assesses the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria for PTSD (Weathers et al., 2013). Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms. Total Score (Range 0-80 with higher scores representing more PTSD symptoms.
14 secondary outcomes
Change in self-rated symptoms of PTSD and complex PTSD measured by The Child and Adolescent Trauma Screen (CATS-2)
Time frame: Baseline, through the treatment period up to 12 weeks and 1-month, 6-month and 12-month after treatment completion
Change in self-rated symptoms of depression as measured by Mood and Feelings Questionnaire (MFQ)
Time frame: Baseline, immediately after treatment completion, and 1-month, 6-month and 12-month after treatment completion
Change in psychosocial impairment measured by The Education, Work and Social Adjustment Scale, Youth and Parent (EWSAS)
Time frame: Baseline, immediately after treatment completion, and 1-month, 6-month and 12-month after treatment completion
Change in Treatment Inventory of Costs in Psychiatric Patients (TIC-P)
Time frame: Baseline, immediately after treatment completion, and 1-month, 6-month and 12-month after treatment completion
Adverse events related to treatment measured by the Negative effects questionnaire
Time frame: Immediately after treatment completion, 1-month, 6-month and 12-month after treatment completion
Quality of life measured by Assessment of Quality of Life KIDSCREEN-10
Time frame: Immediately after treatment completion, 1-month, 6-month and 12-month after treatment completion
Participants satisfaction with treatment, assessed by The Client Satisfaction Questionnaire (CSQ-8).
Time frame: Immediately after treatment completion.
Number of completed treatment modules
Time frame: Baseline up to 12 weeks
Number of messages sent and received in the digital platform
Time frame: Baseline up to 12 weeks
Number of home work assignments made by the participant during the treatment period
Time frame: up to 12 weeks
The proportion of participants that conducts the weekly measures and further assessment points
Time frame: up to the 6 months follow up
The proportion of participants that go through the entire treatment period
Time frame: up to 12 weeks
Number of drop-outs from treatment
Time frame: up to 12 weeks
Participants experience/satisfaction with treatment and assessment procedures through qualitative interviews
Time frame: up to the 6-month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 42203279Mattelin E, Weyler H, Andersson R, Paulsen J, Tielman S, Vikgren A, Bondjers K, Serlachius E, Mataix-Cols D, Bragesjo M. Feasibility and acceptability of therapist-guided, asynchronous, internet-delivered trauma-focused CBT for adolescents with PTSD: a single-group feasibility trial in Sweden. BMJ Open. 2026 May 27;16(5):e117024. doi: 10.1136/bmjopen-2026-117024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erica Mattelin contact
Maria Bragesjö, PhD principal investigator
Karolinska Institutet/Region Stockholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapist-supported internet-delivered trauma-focused CBT and 12 weeks of therapist-supported internet-delivered psychoeducation and stress management/relaxation for both the youth and the care giver. in people with Posttraumatic Stress Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Bragesjö (+46(0)703399387, maria.bragesjo@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale Children and Adolescent version 5 (CAPS-5-CA) (time frame: Baseline, 1-month (primary endpoint), 6-month and 12-month after treatment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06185244, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.